Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)

NCT ID: NCT01448668

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-06-30

Brief Summary

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 3 years.

Prospective observational confirmation study of previous retrospective cohort study.

As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

Detailed Description

see summary

Conditions

Pancreas Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Test group with Iscador® Qu

The test group will receive the mistletoe extract Iscador® Qu as supportive treatment in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

No interventions assigned to this group

Control group

The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
• Age between 18 (Austria: 19) and 85 years
• No previous malign tumor
• ECOG 0-2
• Estimated life expectancy > 3 months
• Surgical resection of the tumor (R0, R1) or determination of interoperability
• Conventional oncological therapy and measurements, or passive after-care ("best care")
• Follow-up for several years feasible
• Patient gives written consent to use the anonymized date for evaluation

Exclusion Criteria

• Other Iscador® sorts than Qu in the test group
• Other mistletoe preparations in the test group
• Any mistletoe preparation in the control group
• Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
• HIV infection, Aids, organ transplantation
• Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever > 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
• Patients participating in another clinical study with non-approved substances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hiscia Society for Cancer Research

UNKNOWN

Sponsor Role: collaborator

IFAG Basel AG, both Switzerland

UNKNOWN

Sponsor Role: collaborator

IFAG AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker Heinemann, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Med. Clinic III, University Clinic Munich Grosshadern

Locations

5th Med., Clinic Hietzing

Vienna, , Austria

University Vienna

Vienna, , Austria

Augusta Clinic

Bochum, , Germany

MVZ Fulda

Fulda, , Germany

University Clinic - Internal Med. I

Halle, , Germany

Hospital Herdecke

Herdecke, , Germany

Med. Clinic III, University Munich Grosshadern

Munich, , Germany

Clinic Kloster Paradiese

Soest, , Germany

University Clinic Ulm

Ulm, , Germany

Countries

Austria; Germany

Other Identifiers

2010-018683-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISC-4.1.6

Identifier Type: -

Identifier Source: org_study_id